‘Valve-in-Valve’ Technique Effective in Treating CoreValve Leaks

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Implanting a second CoreValve device inside a first one is an effective means of treating paraprosthetic leakage in patients undergoing transcatheter aortic valve implantation (TAVI), according to an Italian registry study in the March 1, 2011, issue of the Journal of the American College of Cardiology.

Researchers led by Gian Paolo Ussia, MD, of the University of Catania (Catania, Italy), studied 663 TAVI patients from the Italian CoreValve Registry who received the third-generation device (18 Fr; Medtronic, Minneapolis, MN) at 14 centers across Italy. Twenty-four patients (3.6%) experienced severe paraprosthetic leakage due to device malpositioning and received the valve-in-valve procedure, which involves implantation of a second self-expanding valve that completely overlaps and crushes the leaflets of the first one, in essence leaving a single functioning prosthetic valve.

There were no differences observed in baseline characteristics between patients who did and did not receive the valve-in-valve procedure. Mean annulus diameter was larger in the valve-in-valve group (23.6 ± 2.7 mm vs. 22.1 ± 2.12 mm; P = 0.010). The most common type of device malposition was deployment that was too low inside the left ventricular outflow tract (75% of cases), whereas a higher implantation relative to the aortic annulus occurred less frequently (25%).

Results Maintained Out to 1 Year

Procedural success was high in both the valve-in-valve (100%) and non-valve-in-valve groups (97.9%; P = 0.616). Intraprocedural mortality (0% vs. 0.9%; P = 0.801) and MACCE, defined as death from any cause, MI, stroke, or conversion to open surgery (0% vs. 2.8%; P = 0.510), were similarly low in both groups. There also were no significant differences in complications between the valve-in-valve and non-valve-in-valve groups, including major access site complications (4.2% vs. 3.7%; P = 0.384) or cardiac tamponade (0 vs. 1.2%; P = 0.743).

At 30 days and 12 months, there were no differences between the 2 groups in terms of mortality, MACCE, or the presence of NYHA class III/IV heart failure (table 1).

Table 1. Clinical Outcomes

 

There was a higher incidence of permanent pacemaker implantation in the valve-in-valve group at 30 days (33.3% vs. 14.4%; P = 0.020). At 12 months, mean transaortic gradients were similar between the 2 groups (10.5 ± 5.2 vs. 10.1 ± 4.2; P = 0.838). There were no cases of structural valve deterioration, valve thrombosis, new paraprosthetic leak, impairment of anterior mitral leaflet in case of low deployment, or thromboembolic events in any patient in the valve-in-valve group.

The analysis “demonstrates that the [valve-in-valve] technique is an effective percutaneous approach that may be accomplished with encouraging acute and midterm outcomes when severe [paraprosthetic leak] occurs after TAVI,” the researchers conclude. “This technique can be performed safely as a bailout procedure to avoid surgical conversion.”

They add that the availability of such a bailout “provides a margin of safety and enhances operator confidence. This is important for a nascent technology like TAVI to gain widespread clinical acceptance.”

Procedure Not Overly Difficult

In a telephone interview with TCTMD, Ted Feldman, MD, of Evanston Hospital (Evanston, IL), explained that paraprosthetic leaks can occur with TAVI procedures “if the valve is malpositioned in such a way that instead of having the fabric skirt of the device over the annulus, you have open stent cells. Then you have wide open aortic insufficiency. In that setting, if you don’t do something pretty quickly, the patient won’t tolerate it. So you put in another valve.”

The good news is that the procedure is not overly demanding for those already trained in CoreValve procedures, Dr. Ussia pointed out in an e-mail communication with TCTMD. “This device is forgiving and once the operator is proficient in the basic training for optimal implantation of the valve, it should not be too difficult to manage a situation which simply requires the implantation of an additional device inside the first one,” he said. “Sometimes the navigation and delivery of the second device may pose a challenge, but that too can be managed with the use of snares that help in navigating the device and keeping it coaxial in the aortic lumen.”

Some Important Caveats

However, Dr. Feldman cautioned that (1) these results should not be generalized to the other TAVI device on the market, the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA), and (2) the CoreValve pivotal trial in the United States has only just begun, so it will take time for US operators to accumulate the same level of experience as those in the current study.

Dr. Ussia agreed, but stressed that these are by no means insurmountable obstacles. He acknowledged that “it is not accurate to generalize the results across the 2 platforms as they are distinct, with different dimensions, materials, mechanism of implantation, and most important, delivery systems and methods of deployment.” Nevertheless, conceptually, the technique is the same. “For a low implant of an Edwards valve causing severe regurgitation, the valve-in-valve technique can be used with good results,” Dr. Ussia said.

With regard to ramping up the US experience, Dr. Ussia expressed confidence that this can be done rapidly. “Our paper is based on the experience in the training phase in Italy,” he said. “Thanks to an efficient proctoring program and communication between operators, everyone learned quickly how to deal with this complication. I think it will follow a similar pattern in the United States.”

No Valve-in-Valve Penalty

Dr. Feldman added that once that occurs, the current paper shows the valve-in-valve technique is an effective way of dealing with paraprosthetic leakage. “The message here is at 30 days [and 12 months], there’s no penalty from having to do an urgent valve-in-valve,” he said. “It’s the only therapy for a malpositioned first implant” aside from surgery.

“If the aortic insufficiency is severe enough that you’re going to do a second implant, it’s a much better strategy because you can do it right away, whereas the delay to a surgical bailout is something that some of these patients won’t tolerate,” Dr. Feldman added. He noted that he personally has performed the procedure once with the Edwards valve. “I have had 1 valve malposition that did require a second valve,” Dr. Feldman said. “If the aortic insufficiency is really severe, it’s a fire drill. It’s a real hurry-up activity to get the second valve in.”

Study Details

The mean logistic EuroScore for patients in the registry was 23.0 ± 13.7%. For patients in the valve-in-valve group, the primary device implanted most often was the 26-mm CoreValve device (62.4%), compared with the larger 29-mm device (37.6%). For the non-valve-in-valve group, the rates were 59.3% and 40.7%, respectively.

 

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Source:
Ussia GP, Barbanti M, Ramondo A, et al. The valve-in-valve technique for treatment of aortic bioprosthesis malposition: An analysis of incidence and 1-year clinical outcomes from the Italian CoreValve Registry. J Am Coll Cardiol. 2011;57:1062-1068.

 

 

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